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Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT00940667
First received: July 14, 2009
Last updated: July 15, 2009
Last verified: July 2009
History of Changes
  Purpose

The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and amlodipine alone in patients with essential hypertension inadequately controlled on amlodipine monotherapy.


Condition Intervention Phase
Hypertension
 Drug: Amlodipine plus Losartan
Drug: Amlodipine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, 8-week, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Amlodipine 5mg+Losartan 50mg Versus Amlodipine 10mg in Patients With Essential Hypertension Not Controlled on Amlodipine Monotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Change from baseline in mean sitting diastolic blood pressure [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in mean sitting diastolic blood pressure [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in mean sitting systolic blood pressure [ Time Frame: Week 4, 8 ] [ Designated as safety issue: No ]
  • Responder rate [ Time Frame: Week 4, 8 ] [ Designated as safety issue: No ]

Enrollment: 185
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: amlodipine/losartan 5/50mg Drug: Amlodipine plus Losartan
amlodipine/losartan 5/50mg q.d.
Other Name: Amosartan
Active Comparator: amlodipine 5mg Drug: Amlodipine
amlodipine 5mg q.d.
Other Name: Amodpine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over 18 years of age
  • Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP ≥ 90 mmHg for drug-treated patient, sit DBP ≥ 95 mmHg for drug-naïve patient)
  • Non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit DBP ≥ 90mmHg)

Exclusion Criteria:

  • mean sit SBP ≥ 200 mmHg or mean sit DBP ≥ 120 mmHg at screening
  • mean sit SBP ≥ 180 mmHg or mean sit DBP ≥ 120 mmHg after 4 weeks of amlodipine 5 mg treatment
  • has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
  • Secondary hypertensive patient or suspected to be
  • Uncontrolled diabetes mellitus patients
  • Severe heart disease or severe neurovascular disease
  • Known as severe or malignant retinopathy
  • Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
  • History of malignancy tumor
  • History of autoimmune disease
  • History of alcohol or drug abuse
  • Positive to pregnancy test, nursing mother, has an intention on pregnancy
  • Considered by investigator as not appropriate to participate in the clinical study with othe reason
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940667

Locations
Korea, Republic of
13 sites in Korea
Seoul, Busan, etc., Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Seung-Yun Cho, M.D., Ph.D. Severance Hospital
  More Information

No publications provided by Hanmi Pharmaceutical Company Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT00940667     History of Changes
Other Study ID Numbers: HM-ALOS-301
Study First Received: July 14, 2009
Last Updated: July 15, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:
Amlodipine
Losartan
hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Losartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on June 17, 2013